System and method for mechanical closure of wounds

ABSTRACT

Devices for treating wounds and methods of treating wounds are described. In use, the devices allow both mechanical force and negative pressure therapy.

The present disclosure pertains to devices and methods for woundtreatment, and particularly, to devices and methods that allowmechanical force and reduced pressure therapy.

BACKGROUND

Reduced pressure, or vacuum-assisted, therapies can be effective forimproving wound healing due to a variety of different causes and at anumber of different anatomical locations. Typically, reduced pressuretherapies include a porous material that is placed at a wound site. Amembrane or drape is placed over the porous material to provide anairtight seal at the wound area, and a negative pressure is applied tothe porous material to provide a reduced pressure at the wound site.

Tissue stretching systems can assist with wound closure. Such stretchingsystems may provide mechanical forces to tissue around the wound toallow approximation of the wound margins over time.

SUMMARY

According to certain embodiments, a wound treatment device is providedthat comprises a first body comprising at least one first openingconfigured for attachment to a reduced pressure source and at least onefluid passage extending at least partially through the first body and influid communication with the at least one opening. The device furthercomprises two or more elongated sections, each attached to the firstbody, extending from the first body in different directions, and havinga length that is adjustable with respect to the first body.

According to certain embodiments, a method for treating a wound isprovided that comprises mechanically coupling two or more elongatedsections to tissue at two or more locations around a wound, the two ormore elongated sections being attached to a first body comprising atleast one first opening configured for attachment to a reduced pressuresource and at least one fluid passage extending at least partiallythrough the first body and in fluid communication with the at least oneopening. The method further comprises creating tension in the two ormore elongated sections to pull the tissue at the two or more locationsaround the wound closer together.

According to certain embodiments, a wound treatment device is providedthat comprises a first body having a substantially rigid material body.The device further comprises two or more elongated sections, eachattached to the first body, extending from the first body in differentdirections, and having a length that is adjustable with respect to thefirst body. The device also comprises an adhesive for mechanicallycoupling two or more connectors, each attached to one of the two or moreelongated sections, to tissue surrounding a wound.

According to certain embodiments, a method for treating a wound isprovided that comprises mechanically coupling two or more elongatedsections to tissue at two or more locations around a wound using anadhesive, the two or more elongated sections being attached to a firstmaterial body. The method further comprises creating tension in the twoor more elongated sections to pull the tissue at the two or morelocations around the wound closer together.

DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a wound treatment device, which provides mechanicalforce and reduced pressure therapy, according to certain exemplaryembodiments.

FIG. 2 illustrates an exploded view of the device of FIG. 1.

FIG. 3 illustrates another embodiment of the wound treatment device ofFIG. 1.

FIG. 4 illustrates certain exemplary embodiments of the wound treatmentdevice of FIG. 1, which includes additional elongated sections.

FIG. 5A illustrates an adjustable connector attached to an elongatedsection of a mechanical wound treatment device, according to certainexemplary embodiments.

FIG. 5B illustrates the adjustable connector of FIG. 5A in a shortenedposition.

FIG. 6A illustrates another adjustable connector attached to anelongated section of a wound treatment device, according to certainexemplary embodiments.

FIG. 6B illustrates the adjustable connector of FIG. 6A in a closed andfixed position on the elongated section.

FIG. 7A illustrates an enlarged view of a first body of a woundtreatment device, including a tightening or tension-producing mechanism,according to certain exemplary embodiments.

FIG. 7B illustrates a partial cut-away view of the device of FIG. 7A,showing internal components of the device.

FIG. 8A illustrates a wound treatment device according to certainexemplary embodiments.

FIG. 8B illustrates a partial cut-away view of the device of FIG. 8A,showing internal components of the device.

FIG. 9 illustrates a wound treatment device according to certainexemplary embodiments.

FIG. 10 illustrates a wound treatment device according to certainexemplary embodiments.

FIG. 11 illustrates the wound treatment device of FIG. 10, includingreduced pressure therapy treatment components.

DESCRIPTION OF CERTAIN EXEMPLARY EMBODIMENTS

Reference will now be made in detail to the certain exemplaryembodiments according to the present disclosure, certain examples ofwhich are illustrated in the accompanying drawings. Wherever possible,the same reference numbers will be used throughout the drawings to referto the same or like parts.

The present disclosure pertains to wound treatment devices that can beused to provide mechanical forces to assist in closing, or at leastpartially closing, wounds. In some embodiments, the devices of thepresent disclosure can be configured to provide mechanical forcesdirected at approximating wound margins without damaging surroundingskin or other tissue. In some embodiments, the mechanical forces areapplied without penetrating skin or other tissue. In certainembodiments, the devices provide mechanical forces directed atapproximating wound margins in conjunction with reduced pressuretherapy. In various embodiments, the devices can be used to treat avariety of different wound shapes and at many different anatomicallocations.

In this application, the use of the singular includes the plural unlessspecifically stated otherwise. In this application, the use of “or”means “and/or” unless stated otherwise. Furthermore, the use of the term“including”, as well as other forms, such as “includes” and “included”,is not limiting. Also, terms such as “element” or “component” encompassboth elements and components comprising one unit and elements andcomponents that comprise more than one subunit, unless specificallystated otherwise. Also the use of the term “portion” may include part ofa moiety or the entire moiety.

The section headings used herein are for organizational purposes onlyand are not to be construed as limiting the subject matter described.All documents, or portions of documents, cited in this application,including but not limited to patents, patent applications, articles,books, and treatises, are hereby expressly incorporated by reference intheir entirety for any purpose.

The term “reduced pressure,” as used herein, generally refers to apressure less than the ambient pressure at a tissue site that is beingsubjected to treatment. In most cases, this reduced pressure will beless than the atmospheric pressure at which the patient is located.Alternatively, the reduced pressure may be less than a hydrostaticpressure of tissue at the tissue site. Reduced pressure may initiallygenerate fluid flow in the tube and the area of the tissue site. As thehydrostatic pressure around the tissue site approaches the desiredreduced pressure, the flow may subside, and the reduced pressure is thenmaintained. Unless otherwise indicated, values of pressure stated hereinare gage pressures.

The term “fluid” as used herein generally refers to a gas or liquid, butmay also include any other flowable material, including but not limitedto gels, colloids, and foams.

Although reduced pressure therapy is effective to improve healing timesand reduce complications for many types of wounds, in some cases,additional therapies may help improve results. For example, for largerwounds, there may be insufficient overlying dermal, epidermal, and/orsubcutaneous tissue to cover the entire wound. In such cases, skingrafts or other reconstructive procedures may be used to cover thewound. In certain embodiments, devices described herein can be used toprovide mechanical forces and reduced pressure therapy to assist inwound closure, resulting in wound closure and healing without graftingor other reconstructive procedures. In certain embodiments, devicesdescribed herein can be used to provide mechanical forces and reducedpressure therapy to assist in wound closure, and may be used before,simultaneously with, and/or after grafting or other procedures ortherapies.

In some embodiments, the devices described herein can be used to assistin treating wounds caused by trauma due to injury and/or surgery. Inaddition, some surgical wounds are closed using delayed primary closureor closure by secondary approximation. In certain embodiments, devicesdescribed herein can be used to provide mechanical forces and reducedpressure therapy to assist in wound closure by delayed primary closureor by secondary approximation. Further, certain wounds are caused bydiseases such as diabetes or vascular disease, and may not be due tosurgery or trauma. In certain embodiments, the devices described hereinmay be used to assist in healing of wounds caused by any disease.

Many mechanical wound closure systems include sharp hooks or barbs tograsp the tissue adjacent to the wound. These hooks and barbs may beeffective for short-term application of mechanical forces to thesurrounding tissues, but, when used over more extended times, can causethe adjacent tissue to break down. In certain embodiments, the devicesdescribed herein are able to attach to tissue without hooks or barbs.

In addition, prior mechanical wound closure devices are not compatiblefor use with reduced pressure therapy devices. The devices describedherein are compatible with reduced pressure therapy. In certainembodiments, the devices disclosed herein allow for periodic replacementof the porous material or other procedures used in reduced pressuretherapy.

FIG. 1 illustrates a wound treatment device 100, including a mechanicaltreatment device 110 and reduced pressure therapy device 120, accordingto certain exemplary embodiments, and FIG. 2 illustrates an expandedview of the device 100 of FIG. 1, indicating how the components may beapplied to a patient in certain embodiments. As shown and described inmore detail below, the mechanical treatment device 110 includes a firstbody 130 and two or more elongated sections 140 attached to andextending from the first body 130. The elongated sections 140 areconfigured to be attached to tissue around a wound or to a flexiblesheet 160 overlying the wound and attached to tissue around the wound.The elongated sections 140 can be positioned to provide forces directedat pulling the wound margins together, and the forces can be controlledby adjusting the length of the elongated sections 140 using a tighteningmechanism of the first body 130.

Further, in some embodiments, the device 100 can include a reducedpressure therapy device 120. As shown, the reduced pressure therapydevice 120 can include a pump 122 fluidly connected to the mechanicaltreatment device 110, e.g., through a fluid passage or tubing 124. Insome embodiments, the first body 130 of the mechanical treatment device110 can include a fluid or suction connector 126 configured to becoupled with the fluid passage or tubing 124. The connector 126 can befluidly coupled with the space underlying the first body 130, therebyproviding suction or reduced pressure to the wound site. Accordingly,the first body 130 can provide a fluid connection between the fluidpassage 124 and the wound site. As noted, in some embodiments, themechanical treatment device 110 can be designed to allow adjustablemechanical forces to be applied to tissue surrounding wounds, whileallowing reduced pressure therapy to be administered.

The mechanical treatment device 110 can provide tension to wound marginsfor a variety of different wound shapes and at various anatomical sites.For example, as shown in FIGS. 1 and 2, the device 110 includes sixelongated sections 140 extending on substantially opposite sides of anelongated, or substantially linear wound site 150 (labeled in FIG. 2).As shown in FIGS. 1 and 2, the elongated sections 140 can be formed froma flexible material, such as a wire, cord, or string, attached to adistal connector 142, which is configured to engage tissue (e.g., skin)or a flexible sheet 160 overlying the wound site 150. In someembodiments, the elongated sections can be formed from elastic orflexible polymeric materials.

As noted, FIG. 1 illustrates a mechanical treatment device 110 includingsix elongated sections 140, but the number of elongated sections 140 canbe varied. In certain embodiments, the number of elongated sections 140may relate to the intended use, the shape or size of the wound to betreated, and/or the anatomical site of the wound. In some embodiments,the mechanical treatment device 110 will include at least two elongatedsections, at least three elongated sections, at least four elongatedsections, at least five elongated sections, at least six elongatedsections, at least seven elongated sections, or at least eight elongatedsections. In various embodiments, any suitable number of elongatedsections can be selected based on the specific wound to be treated.

In addition, in various embodiments, the orientation and/or length ofthe elongated sections 140 can be varied. In certain embodiments, theorientation and/or length is based on the specific wound to be treated.For example, as shown in FIG. 1, three elongated sections are placed oneach side of an elongated wound, thereby allowing the wound edges to bepulled towards one another. However, as few as two elongated sections140 can be used, each being disposed on opposite sites of a wound topull the wound margins towards one another.

In certain embodiments, for more round and/or irregular wounds, theorientation of each of the elongated sections 140 with respect to thefirst body 130 can be selected to control the direction and magnitude ofthe forces exerted on surrounding tissue. Further, in certainembodiments, the flexible nature of the elongated sections 140 willallow a high degree of control so that a surgeon or other health careworker can treat wounds having a wide range of sizes and shapes. Inaddition, in various embodiments, more elongated sections 140 may beused for more irregular or larger wounds, as described further below.

In various embodiments, the first body 130 and elongated sections 140can include a variety of different structures and/or materials. Forexample, as shown, the elongated sections 140 can include elongated,flexible wires or cords. These wires or cords can be formed from avariety of suitable materials, including, but not limited to, metalsand/or synthetic or naturally occurring polymers. In variousembodiments, the elongated sections 140, can be braided, laminated, orof unitary structure. In various embodiments, the specific material anddimensions can be selected based on the amount of force that may beapplied to the elongated sections 140 and/or the degree of flexibilitysuitable for the selected anatomic site. In some embodiments, the firstbody 130 (as well as the first bodies described below 230, 830, 930) canbe produced from a rigid material, such as a rigid plastic or metal,that can withstand tension exerted by elongated extensions 140. Incertain embodiments, part or all of the first body 130 can be softer ormore pliable.

As noted, the mechanical treatment device 110 can be configured toprovide mechanical forces to assist in wound closure, while providingreduced pressure therapy. In various embodiments, a variety of reducedpressure therapy devices can be used. For example, suitable reducedpressure therapy devices include V.A.C.® therapy devices produced byKinetic Concepts, Inc (San Antonio, Tex.). Such reduced pressure therapydevices can include a vacuum pump, similar to the pump 122 shown in FIG.1, which can be fluidly connected to the first body 130 of themechanical treatment device 110. Such devices may also include aflexible sheet 160 to cover the wound site 150 and at least partiallyseal the wound to allow reduced pressure therapy to be provided at thewound site. In addition, such systems may include a porous material ordressing 180, that is placed at the wound site and facilitates woundclosure, healing, tissue regeneration or repair, prevents or treatsinfection, and/or has other beneficial effects.

In some embodiments, the flexible sheet 160 will include a flexiblepolymeric material. In various embodiments, any suitable polymericmaterial can be selected. In various embodiments, the material does notcause significant irritation, immune response, or heightened risk ofinfection. In various embodiments, the specific material generallyshould be of sufficient thickness and impermeability to allow reducedpressure therapy at a wound site under the sheet 160. In someembodiments, the connectors 142 may be attached to the flexible sheet160, while the flexible sheet 160 is attached to underlying skin orother tissue. Accordingly, in various embodiments, the mechanical forcesgenerated by the mechanical treatment device 110 will be at leastpartially transmitted through the sheet 160, and therefore, the specificmaterial thickness and physical properties will be selected to withstandsuch physical demands.

In some embodiments, the device 100 will include an adhesive. As usedhere, and throughout the disclosure, adhesive will be understood torefer to any substance that causes the surfaces of two objects to beattached to one another. In various embodiments, suitable adhesives caninclude a variety of different cements, glues, resins, or othermaterials that can facilitate attachment of the flexible sheet 160 totissue or to other components of the device 100. In some embodiments,the adhesive can include a pressure-sensitive acrylic adhesive. Invarious embodiments, the adhesives can be applied directly to thestructures to be joined, or the adhesives may be applied on tape, orwith other supporting substrate materials.

In some embodiments, the adhesive can be applied to a surface of theflexible sheet 160 to attach the sheet to skin or other tissue. In someembodiments, the adhesive will be applied to the surface of the sheetand packaged and/or distributed with the sheet 160. In some embodiments,the adhesive is applied to a surface of the sheet 160 and covered by anonadhesive material that can be removed to expose the adhesive for use.In certain embodiments, the adhesive can be supplied as a separatecomponent (e.g., in a container or on a tape) that is applied to thesheet 160 to attach the sheet 160 to tissue.

In various embodiments, the porous material 180 can include a variety ofsuitable materials. For example, a number of different dressingmaterials are available for use with the above-noted V.A.C.® treatmentsystems. Such dressings can include, but are not limited to, porousopen-cell foam structures, such as open-cell polyurethane. In variousembodiments, other materials containing various therapeutic substancescan be selected for use with the devices of the present disclosure, andin various embodiments, the specific dressing may be selected based onthe particular wound to be treated.

As noted previously, in some embodiments, the connectors 142 attached tothe elongated sections 140 can be attached to skin or other tissue, orto the flexible sheet 160 covering a wound site 150 and dressing 180.Certain exemplary configurations for the connectors 142 are described inmore detail below. In some embodiments, the connectors 142 can beconfigured to attach to the flexible sheet, skin, or other tissuewithout penetrating the sheet, skin, or other tissue. For example, insome embodiments, an adhesive may be placed on an undersurface 516 ofthe connectors 142 to allow the connectors 142 to be attached to thesheet, skin, or other tissue without penetrating the skin. In someembodiments, the adhesive can include the same adhesive selected toattach the flexible sheet 160 to the patient. In some embodiments, theadhesive can include a pressure-sensitive acrylic adhesive. In someembodiments, the adhesive can be a cyanoacrylate adhesive.

In some embodiments, the connectors 142 can have at least one dimensionthat is enlarged compared to the elongated sections 140. In someembodiments, the connectors 142 are wider than the elongated sections140 to which they are attached. In certain embodiments, the connectors142 have a larger surface area relative to their length to provide alarger surface of attachment.

In various embodiments, the method of attachment of the connectors 142to the elongated sections 140 can be varied. In certain embodiments, theconnectors 142 can be removably attached to the elongated sections 140.In other embodiments, the connectors 142 can be permanently attached tothe elongated sections 140. In some embodiments, the connectors 142 canbe formed from the same piece of material that forms the elongatedsections 140. In certain embodiments, the connectors 142 can be formedfrom a different piece of material, but can be permanently attached witha weld, chemical bond, or adhesive attachment.

In some embodiments, as shown in FIG. 2, the flexible sheet 160 can beattached over a wound site 150, with at least part of the mechanicaltreatment device 110 attached to a top surface of the flexible sheet160. In certain embodiments, the wound is first cleaned and otherpreparatory procedures are performed. Next, after preparing the wound, aporous material 180 or dressing is selected and cut to an appropriatesize before being placed at the wound site 150. Then, after the dressingis positioned in the wound, the flexible sheet 160 is attached over thewound site 150, with the edges of the sheet 160 overlying the woundmargins a sufficient distance to allow a seal to be formed to performreduced pressure therapy.

After the dressing and sheet are positioned over the wound, the firstbody 130 of the mechanical treatment device 110 is attached to the sheet160. In some embodiments, the sheet 160 will include a preformed openingor fluid passage to allow the mechanical treatment devices to beattached. In some embodiments, the first body 130 and sheet 160 may beproduced and/or distributed as a single unit that is already assembled.In some embodiments, a surgeon can use a sheet having no opening orpreformed attachment for the first body 130, but may produce the openingand attach the first body 130 using an adhesive, such as that used toattach the connectors 142 and/or sheet 160. In some embodiments, thesheet 160 can include a tubular member attached to the sheet 160 througha preformed passage, and the first body 130 can be configured to attachto this tubular member to provide fluid communication with an underlyingwound.

After the first body 130 is attached to the sheet 160, the connectors142 can be positioned on the sheet 160. As noted previously, theconnectors 142 may be attached to the sheet 160 using an adhesive toattach undersurfaces 516 of the connectors 142 to the sheet.Accordingly, with the sheet 160 being adhesively attached to thepatient's skin or other tissue, and the mechanical treatment device 110being attached to the sheet 160, forces generated in the elongatedsections 140 are transmitted to the patient's tissue, therebymechanically coupling the device 110 to the area surrounding the woundand drawing the wound margins closer together.

In certain embodiments, the mechanical wound treatment device 110 can beattached directly to the skin or other tissue around a wound site tomechanically couple the device 110 to the tissue around the wound anddraw the wound margins closer together. For example, FIG. 3 illustratescertain embodiments of the wound treatment device 100 of FIG. 1. Asshown, the device 100 again includes a mechanical wound treatment device110 having a number of elongated sections 140 extending in differentdirections from a first body 130. The first body 130 further includes aconnector 126 configured to engage a reduced pressure therapy device120, as described previously. However, in such embodiments, themechanical treatment device 110 is attached to tissue surrounding thewound site before the flexible sheet 160 is applied to seal the wound.Therefore, the undersurfaces 516 of the connectors 142 are adhesivelyattached directly to skin or other tissue. Further, the fluid passage ortubing 124 of the reduced pressure therapy device 120 can pass under thesheet 160. Alternatively, in various embodiments, the fluid passage 124and/or the first body 130 of the mechanical treatment device 110 canprotrude through an opening (not shown) formed in the sheet 160, therebyallowing access to these elements when the sheet is applied.

As shown in FIG. 3, in some embodiments, the sheet 160 may be sized suchthat when placed over the mechanical wound treatment device 110, thesheet will cover the first body 130, the elongated sections 140, andeach of the connectors 142. In some embodiments, the sheet 160 coversthe first body 130 and wound, while the connectors 142 are not coveredby the sheet 160, but remain attached to tissue. In some embodiments,the sheet 160 will be sized so that one or more connectors 142 are notcovered to allow easy manipulation of the connectors 142.

As noted previously, in various embodiments, the wound treatment devicesof the present disclosure can be used to treat wounds having a varietyof different types, shapes, sizes, and locations. For example, FIG. 4illustrates certain embodiments of the wound treatment device 100 ofFIG. 1, being used to treat a more irregularly shaped wound 155. Variouselements in FIG. 1 that are not shown in FIG. 4 can be used with theembodiments in FIG. 4.

As shown in FIG. 4, the mechanical treatment device 110 includes eightelongated sections 140 extending in various directions. Further, thepositions of the connectors 142 with respect to the margins of the wound155 have been adjusted to conform to the irregularities of the wound155. Therefore, in various embodiments, the mechanical treatment devicesprovide flexibility in treating a variety of different shapes and sizesof wounds by allowing control of the number, length, and position ofelongated sections that produce tensile forces to assist in tissuestretching and/or wound closure.

In addition to adjusting positions of the connectors 142 by moving theelongated sections 140, the length and position of the elongatedsections 140 and/or connectors 142 can be controlled in a number ofother ways to allow the connectors 142 to be appropriately positionedaround a wound. For example, in some embodiments, the length of theconnectors 142 can be adjusted. In other embodiments, the position atwhich the connectors 142 attach to the elongated sections 140 can beadjusted to control the distance from the first body 130 to theconnectors 142.

In some embodiments, the connectors 142 can include an adjustablelength, thereby allowing control of the distance from the first body 130to the position of attachment of the connector 142 to the patient'stissue or the sheet 160. FIGS. 5A-5B illustrate certain embodiments ofan adjustable connector 142. FIG. 5A illustrates the adjustableconnector in a more elongated configuration, and FIG. 5B illustrates theadjustable connector of FIG. 5A in a shortened configuration.

As shown, the connector 142 includes a tab portion 504 having a seriesof notches or ridges 508 along its length. Further, a proximal end 505of the tab portion 504 is attached to the elongated section 140. Theconnector 142 further includes a tab receiving portion 500 having anundersurface 516 that can be adhesively attached to a patient's tissueor a flexible sheet 160, as described above. As shown, the tab receivingportion 500 includes an opening and passage 510 configured to receivethe tab portion 504. Further, as the tab portion 504 is advanced intothe passage 510, the ridges or notches 508 will engage an inwardlyprotruding portion 514 of a locking mechanism 512, thereby securing thetab portion 504 within the tab receiving portion 500. In someembodiments, the locking mechanism 512 prevents sliding movement of thetab portion 504 within the tab receiving portion 500 in one direction,while allowing sliding movement in the opposite direction. In someembodiments, the locking mechanism 512 allows the tab portion 504 toslide into the tab receiving portion 500, thereby shortening thedistance from the tab receiving portion 500 to the end of the elongatedsection 140 attached to the tab portion 504, and prevents movement ofthe tab portion 504 out of the tab receiving portion 500, therebypreventing an increase in the distance from the tab receiving portion500 and the end of the elongated section 140 attached to the tab portion504.

As shown, the tab portion 504 can be advanced a desired distance withinthe tab receiving portion 500, thereby adjusting the distance betweenthe tab receiving portion 500 and the end of the elongated section 140attached to the tab portion 504, and controlling the overall length ofthe connector 142. For example, as shown in FIG. 5B, the tab portion 504can be advanced nearly completely to shorten the distance between thetab receiving portion 500 and the end of the elongated section 140attached to the tab portion 504. Alternatively, by advancing the tabportion 504 a shorter distance into the tab receiving portion 500, thedistance between the tab receiving portion 500 and the end of theelongated section 140 attached to the tab portion 504 can be increased.

The length of the connectors 142 can be adjusted either before theconnectors 142 are attached to a patient's tissue or a sheet 160 orafter the connectors 142 are attached to the patient's tissue or sheet160. In some embodiments, the tab receiving portion 500 is attached totissue or a sheet 160, and then the tab portion 504 is inserted oradjusted within the tab receiving portion 500 to produce increasedtension in the elongated section 140 attached to the tab portion 504. Insome embodiments, the tab portion 504 is adjusted to a selected positionwithin the tab receiving portion 500, and then the tab receiving portion500 is attached to tissue or the sheet 160.

In various embodiments, the distance of the connectors from the firstbody 130 can be controlled by adjusting the position of the connectorsalong the elongated section 140. FIGS. 6A-6B illustrate an adjustableconnector 600 and an elongated section 140 of a wound treatment device,according to certain exemplary embodiments. In these embodiments, theconnector 600 is adjustably positioned along the length of the elongatedsection 140. As shown, the connector 600 includes a connector main body604 and a locking body 608. In some embodiments, the locking body 608includes an opening 612 for receiving the elongated section 140, whilethe connector main body 604 includes a groove 620 for receiving theelongated section 140. In some embodiments, a cover 630 is attached tothe top of the main body 604 to cover the groove 620.

As shown in FIG. 6A, the connector 600 can be adjusted along the lengthof the elongated section 140. Then, in order to lock the connector 600in place, the locking body 608, with the elongated section 140 passingthrough the groove 620 and opening 612, is pushed into a slot 610 of theconnector main body 610, thereby applying pressure to the elongatedsection 140 to crimp the elongated section 140 and secure the connector600 in place along the elongated section 140.

In various embodiments, the locking body 608 and slot 610 can be sizedsuch that a press fit connection is formed upon inserting the lockingbody 608 into the slot 610, along with the elongated section 140. Insome embodiments, the pressure formed by this connection will besufficient to hold the connector 600 in place on the elongated section140. In some embodiments, an adhesive or other connection mechanism maybe used to secure the locking body 608 within the slot 610.

In a manner similar to the connector 142, the connector 600 can beattached to a patient's tissue or a sheet 160 using an adhesive. Incertain embodiments, after the connector 600 is positioned on theelongated section 140 and fixed in place, as described above, anadhesive can be applied to, or exposed on (e.g., on a surface of two-waytape), a bottom surface 616 of the connector 600 or a tissue or sheetsurface to which the connector 600 is to be attached. Further, asdescribed above, in certain embodiments, after each of the connectors600 have been attached to the patient's tissue or the sheet 160, themechanical treatment device can be tightened to produce a desired degreeof tension in the tissue surrounding the wound.

In various embodiments, the first body 130 can include a number ofmechanisms to facilitate tightening of the elongated sections 140 toproduce the desired amount of tension in the surrounding tissue. In someembodiments, the first body 130 can include a rotatable portion forshortening the elongated sections 140, thereby increasing tension and/orstretching surrounding tissue.

FIG. 7A illustrates an enlarged view of the first body 130, according tocertain exemplary embodiments, and FIG. 7B illustrates a partial cutawayview of the first body 130 of FIG. 7A. As shown, the elongated sections140 extend from the first body 130 in various directions. Further, asnoted previously, in various embodiments, the number and position ofeach elongated section 140 can vary or be adjusted based on theparticular wound to be treated.

As shown in FIGS. 7A and 7B, the first body 130 includes a rotatableportion 700. In various embodiments, the rotatable portion 700 isoperably engaged with an internal wall 720 (shown in FIG. 7B) to whichthe elongated sections 140 are attached. In some embodiments, theinternal wall 720 has a substantially cylindrical shape, and theelongated sections 140 are attached to the surface of the internal wall720. Therefore, as the rotatable portion 700 is rotated, the internalwall 720 rotates. As the internal wall 720 rotates, the elongatedsections 140, which are attached to the internal wall 720, are at leastpartially wrapped around the internal wall 720. In some embodiments,wrapping of the elongated sections 140 around the internal wall 720causes the distance that the elongated sections 140 extend from thefirst body 130 to be decreased to produce a desired tension in tissueattached to the connectors 142 or the sheet 160, as described above. Insome embodiments, rotation of the rotatable portion 700 in one directiondecreases the distance that the elongated sections 140 extend from thefirst body 130. In certain embodiments, rotation of the rotatableportion 700 in a second direction opposite the first direction increasesthe distance the elongated sections 140 extend from the first body 130.

In various embodiments, it will be desirable to immobilize the rotatableportion 700, and therefore fix the length that the elongated sections140 extend from the first body 130 after tightening to a desired degree.Therefore, in some embodiments, the first body 130 can further include alocking mechanism 730 operably engaged with the inner wall 720 and/orrotatable portion 700. In some embodiments, the locking mechanism 730can be configured to allow rotation or tightening in one direction butnot the other, thereby allowing tightening by twisting the rotatableportion 700, and preventing loosening by preventing counter rotation. Insome embodiments, the locking mechanism 730 can include a ratchetmechanism or a ratchet and pawl, as are known in the art. Further, incertain embodiments, the ratchet mechanism can be reversible to allowtightening and loosening when desired. In various embodiments, the firstbody 130 can include a release mechanism 735. In some embodiments, therelease mechanism 735 can include a button or switch that can controloperation of the locking mechanism 730 to engage, disengage, or reversedirection of the locking mechanism 730. In some embodiments, the releasemechanism 735 can reverse the direction of operation of the lockingmechanism 730 to allow rotation in a first direction but not a seconddirection, or to allow rotation in the second direction but not thefirst direction. In some embodiments, the release mechanism 735 candisengage the locking mechanism 730 to allow rotation in eitherdirection.

As shown, in certain embodiments of FIGS. 7A and 7B, the first body 130can further include an outer wall 708 having openings 710 through whichthe elongated sections 140 can pass before attaching to the inner wall720. In some embodiments, these openings can have a fixed position aboutthe periphery of the first body 130. In some embodiments, the openingsdoes not move as the rotatable portion 700 is moved, thereby controllingthe direction along which the elongated sections 140 exert force onsurrounding tissue, even as the elongated sections 140 are tightened.

In addition, as noted previously, in some embodiments, the woundtreatment devices 100 can allow mechanical treatment in conjunction withreduced pressure therapy. Accordingly, as shown in FIG. 7B, the firstbody 130 further includes a connector 126 configured to engage the fluidpassage 124 of a reduced therapy system pump 122. As shown, theconnector 126 includes an opening 128 that can be fluidly connected withthe fluid passage 124. The opening 128 is in fluid communication with afluid passage 129 that passes through the first body 130 and is in fluidcommunication with a wound and dressing to provide reduced pressuretherapy.

FIG. 8A illustrates a wound treatment device 200, according to certainexemplary embodiments. As shown, the device 200 includes a mechanicaltreatment device 210, also including a first body 230, similar to firstbody 130. Further, the device 210 includes a number of elongatedsections 140 extending at various directions and being attached to asheet 160 overlying and sealing a wound to be treated. As shown, theelongated sections 140 are attached to the sheet using connectors 600,as described with respect to FIGS. 6A and 6B. In various embodiments,any of the connectors described herein may be used.

FIG. 8B illustrates a partial cut-away view of the device of FIG. 8A,showing internal components of the device. As shown, the first body 230includes a rotatable portion 250 attached to a spool or tighteningmechanism 240. Each of the elongated sections 140 are attached to thespool or tightening mechanism, so that as the rotatable portion 250 isrotated, the tightening mechanism is engaged to increase tension in theelongated sections 140, thereby pulling wound margins mechanicallycoupled to the connectors 600 closer together.

Further, as described above with respect to the first body 130, incertain embodiments, the device 200 can include an internal lockingmechanism, such as a ratchet system that allows rotation in onedirection, while preventing counter rotation. In some embodiments, thespool or tightening mechanism 240 can include a series of gears toprovide a mechanical advantage, allowing increased tension to beproduced in the elongated sections 140 without excessive effort directedat turning the rotatable portion 250.

In certain embodiments, as noted above, the first body 230 can beconfigured to facilitate mechanical wound closure, while allowingreduced pressure therapy. Accordingly, in certain embodiments, the firstbody 230 can include a fluid connector 226 that can be fluidly coupledwith a pump 122 via a fluid passage 124. The fluid connector 226 caninclude an opening 228 and can communicate with a fluid passage 229traversing the first body 230 to provide fluid communication with awound.

FIG. 9 illustrates certain exemplary embodiments of a wound treatmentdevice 900. As with certain previously described devices, the device 900includes a first body 930 having two or more elongated sections 940extending from the first body 930 and including connectors 942configured to be adhesively attached to a patient's tissue or a flexiblesheet 160 (not shown) using at surfaces 916. Further, the device 900includes a connector 926 configured to engage a reduced pressure therapydevice 120, as described previously.

In these embodiments, however, each of the elongated sections 940 areadjustably connected to the first body 930 at elongated sectionreceiving portions 946. Here, proximal end portions 950 of the elongatedsections 940 are passed through the elongated section receiving portions946, which, in some embodiments, include a female connector openingconfigured to receive a corresponding proximal end portion 950 forming amale connector portion of the elongated sections 940. Further, the endportions 950 can be pulled further through the attachment regions 946 toshorten the length of each elongated section 940 extending from thefirst body 930 to produce the desired tension in each elongated section940. In some embodiments, after adjusting the length of the elongatedsections 940, the end portion 950 may be removed or cut off to reducethe device size and allow placement of an overlying sheet, if desired.In some embodiments, the elongated sections 940 can include small ridgesor notches 908 to allow the elongated sections 940 to be pulled throughthe elongated section receiving portions 946, and provide a lockingmechanism that prevents the elongated sections 940 from being pulledback out of the openings after tightening. In various embodiments, thespecific locking mechanism can be selected based on the desired degreeof tension to be produced, but one suitable mechanism is similar to thatused in devices conventionally described as plastic handcuffs or ties.

As noted above, in various embodiments the wound treatment devices canbe used for wounds having linear or irregular shapes. FIG. 10illustrates a mechanical wound treatment device 810 for use withsubstantially linear wounds, according to certain embodiments, and FIG.11 illustrates the wound treatment device of FIG. 10, along with areduced pressure treatment device. As shown, the device 810 includes afirst body 830. Two pairs of elongated sections 840, 840′ extend fromthe first body 830. In certain embodiments, each of the elongatedsections 840, 840′ includes a pair of substantially parallel elongatedarms. In addition, a connector 842, 842′ extends between first endregions 841, 841′ of each pair of elongated arms of the elongatedsections 840, 840′, forming a flattened or enlarged region that can beattached to a patient's skin or other tissue, or to a sheet 160overlying a wound. Each of the arms of the elongated sections 840, 840′can pass through openings 812 in the first body 830 and will extend tosecond ends 882, 882′ of the elongated arms on opposite sides of thefirst body 830 from the connectors 842, 842′. In certain embodiments,handle regions 880, 880′ extend between the second end regions 882, 882′of each of the pair of elongated arms.

As noted, the connectors 842, 842′ may be attached to tissue or a sheetaround a wound site. In some embodiments, the connectors 842, 842′ canbe attached using an adhesive, as described previously, thereby allowingforce to be exerted on tissues surrounding the wound without penetratingskin or other tissue.

In some embodiments, after the connectors 842, 842′ are attached totissue surrounding a wound, or to a sheet 160 overlying a wound, theconnectors 842, 842′ can be pulled together to exert forces that assistin closing the wound or approximating wound edges. This force can beproduced by pulling the handle regions 880, 880′ apart in the direction860, 860′ indicated in FIG. 10, thereby drawing the connectors 842, 842′together in the direction 864, 864′ indicated in FIG. 10.

In certain embodiments, in order to keep the connectors 842, 842′ inplace, thereby allowing continued force to be applied to wound margins,the first body 830 and elongated sections 840, 840′ can include alocking mechanism. For example, in certain embodiments, the elongatedsections 840, 840′ can include ridges or notches 808 along at least oneof their surfaces, and the first body 830 can include an inner mechanismthat prevents movement of elongated sections 842, 842′ in one or bothdirections.

In some embodiments, the first body 830 can include additional openings828 to receive elongated sections. In some embodiments, the additionalopenings 828 can be positioned to allow the elongated sections 840, 840′to be positioned at different positions along the length of the firstbody 830. In some embodiments, the openings 812 and additional openings828 can be configured to receive elongated sections having otherconfigurations. For example, in certain embodiments, the elongatedsections 940 (as shown in FIG. 9) can be used with the first body 830shown in FIG. 10. In some embodiments, two or more of the elongatedsections 940 will attached to the first body 830 so that elongatedsections 940 extend in opposite directions from the first body 830. Insome embodiments, multiple elongated sections 940 will extend from thefirst body 830 to provide mechanical forces along the length of a linearwound.

As noted previously, the mechanical treatment devices of the presentdisclosure can be designed to facilitate mechanical treatment to assistin wound closure, while allowing reduced pressure therapy. Accordingly,the device 810 can include a fluid connector 826 configured to connectto a fluid passage 124 of a reduced pressure therapy device, as shown inFIG. 11. As discussed above, in certain embodiments, the fluid connector826 can be fluidly connected with fluid passages that transverse thefirst body 830, providing fluid communication with a wound siteunderlying the device 810. In some embodiments, the fluid connector 826can be connected to a fluid passage passing downward to a bottom surfaceof the first body 830. In some embodiments, the fluid passages may bepositioned along the side or at other positions along the first body830. For example, in some embodiments, one or more of the openings 828can form fluid passages in fluid communication with the fluid connector826.

In certain embodiments, after the device 800 has been attached to awound and the reduced pressure therapy pump 122 has been engaged, asheet 160 can be placed over the apparatus 800 to seal the wound andallow both mechanical treatment and reduced pressure therapy. In someembodiments, the sheet can include an opening 162 to allow the fluidconnector 826 to pass through the sheet. In addition, like certaindevices described above, in certain embodiments, the sheet 160 may bepositioned under the mechanical treatment device 800, and the device canbe adhesively attached to the sheet 160 to transmit mechanical forces totissues located beneath the sheet 160.

In certain embodiments, in order to allow a flexible connection with avariety of anatomical sites, the elongated sections 840, 840′ andconnectors 842, 842′ can be formed of a flexible material, as shown.However, in certain embodiments, a more rigid design may be selectedbased on the particular anatomic site and wound to be treated.

In various embodiments, the devices of the present disclosure can beused to treat wounds at numerous different anatomical sites. Further,although the devices are shown with one size, in various embodiments,the devices can be scaled based on the particular patient and anatomicsite to be treated. In addition, although the devices are described foruse with reduced pressure therapy, in various embodiments, themechanical treatment devices of the present disclosure may be usedalone, or without reduced pressure therapy systems, especially where itis desired to provide mechanical assistance for wound closure withoutpenetrating skin or other tissue.

Other embodiments will be apparent to those skilled in the art fromconsideration of the specification and practice of the devices andmethods disclosed herein.

What is claimed is:
 1. A wound treatment device, comprising: a firstbody comprising at least one first opening configured for attachment toa reduced pressure source and at least one fluid passage extending atleast partially through the first body and in fluid communication withthe at least first one opening; two or more elongated sections, eachattached to the first body, extending from the first body in differentdirections, and having a length that is adjustable with respect to thefirst body; and a sheet of flexible material having a perimeter; whereinthe sheet of flexible material is configured to contact a surface alongits perimeter; and wherein the first body is configured to maintain anegative pressure beneath the sheet of flexible material while the sheetof flexible material is in contact with the surface along its entireperimeter.
 2. The device of claim 1, wherein each of the two or moreelongated sections are flexible.
 3. The device of claim 1, furthercomprising two or more connectors, each being attached to one of theelongated sections.
 4. The device of claim 3, wherein the connectors areadjustably positioned along the length of each of the two or moreelongated sections.
 5. The device of claim 3, wherein the connectorseach comprise a tab portion and a tab receiving portion configured toslidably engage the tab portion such that a distance between the tabreceiving portion and an end of one of the elongated sections attachedto the tab portion is adjustable.
 6. The device of claim 5, wherein eachof the connectors comprises a locking mechanism that prevents slidingmovement of the tab portion within the tab receiving portion in at leastone direction.
 7. The device of claim 6, wherein the locking mechanismcomprises a plurality of ridges positioned on a surface of the tab. 8.The device of claim 1, wherein the two or more elongated sectionscomprise two elongated sections extending in substantially oppositedirections from the first body.
 9. The device of claim 8, wherein eachof the two elongated sections, comprise: a pair of substantiallyparallel elongated arms adjustably connected to the first body; and aconnector extending between first ends of the pair of elongated arms andpositioned on a first side of the first body.
 10. The device of claim 9,wherein each pair of elongated arms extends from the first endspositioned on one side of the first body to second ends positioned on anopposite side of the first body and each connector of the two elongatedsections is located on an opposite side of the first body from oneanother; and the two elongated sections each further comprise a handleregion extending between the second ends of the pair of elongated armsof each of the two elongated sections, such that a force applied to eachof the handle regions to move the handle regions further apart from oneanother causes each connector of the two elongated sections to movecloser to one another.
 11. The device of claim 10, wherein the firstbody comprises additional openings passing through the first body, andeach of the elongated arms passes through one of the additional openingssuch that the connector extending between the first end of each pair ofelongated arms is on an opposite side of the first body from the handleextending between the second end of each pair elongated arms; and theelongated arms and the first body form a locking mechanism that preventsmovement of the elongated arms within the additional openings in atleast one direction.
 12. The device of claim 1, comprising at least sixelongated sections extending outwardly from the first body.
 13. Thedevice of claim 1, wherein the first body comprises two or moreelongated section receiving portions, each elongated section receivingportion configured to receive an end portion of one of the elongatedsections such that each of the elongated sections can be adjustablymated with the first body.
 14. The device of claim 13, wherein theelongated section receiving portions and the elongated sections form alocking mechanism such that the elongated sections can be passed intothe elongated section receiving portions but cannot be pulled out of theelongated section receiving portions.
 15. The device of claim 14,wherein the locking mechanism comprises a plurality of ridges positionedon a surface of each of the elongated sections.
 16. The device of claim1, wherein the first body comprises a rotatable portion comprising anattachment mechanism for attachment to each of the elongated sections.17. The device of claim 16, wherein rotation of the rotatable portion ina first direction decreases the length that each of the elongatedsections extends from the first body.
 18. The device of claim 17,wherein rotation of the rotatable portion in a second direction that isopposite the first direction increases the length that each of theelongated sections extends from the first body.
 19. The device of claim16, wherein the at least one fluid passage passes through the rotatableportion.
 20. The device of claim 1, further comprising an adhesive. 21.The device of claim 20, wherein the adhesive is located on surfaces ofconnectors that are attached to each of the elongated sections.
 22. Thedevice of claim 1, further comprising: a porous material body positionedat least partially beneath the first body; a tubular member having anend portion configured to engage the first opening of the first body;and a pump system configured to produce a reduced pressure within thetubular member.
 23. A wound treatment device, comprising: a rotatableportion comprising at least one first opening configured for attachmentto a reduced pressure source and at least one fluid passage extendingthrough the rotatable portion and in fluid communication with the atleast one first opening; and two or more elongated sections, eachelongated section attached to the rotatable portion, extending from therotatable portion in different directions, and having a length that isadjustable with respect to the rotatable portion.
 24. The device ofclaim 23, further comprising two or more connectors, each being attachedto one of the elongated sections; and wherein the connectors have awidth that is greater than a width of each of the elongated sections.25. The device of claim 23, comprising at least four elongated sectionsextending outwardly from the first body.
 26. The device of claim 23,wherein the rotatable portion comprises a locking mechanism configuredto allow the rotatable portion to rotate in one direction but not rotatein a second direction opposite the first direction.
 27. The device ofclaim 26, wherein the locking mechanism comprises a release mechanismthat reverses the locking mechanism to allow the rotatable portion torotate in the second direction but not in the first direction.
 28. Thedevice of claim 26, wherein the locking mechanism comprises a releasemechanism that allows the rotatable portion to rotate in the firstdirection and the second direction.
 29. The device of claim 23, furthercomprising an acrylic adhesive.
 30. The device of claim 23, furthercomprising a sheet of flexible material.
 31. A wound treatment device,comprising: a first body comprising at least one first openingconfigured for attachment to a reduced pressure source and at least onefluid passage extending at least partially through the first body and influid communication with the at least one first opening; and three ormore elongated sections, each attached to the first body, extending fromthe first body in radial directions, and having a length that isadjustable in the radial direction with respect to the first body;wherein at least one of the three or more elongated sections forms anangle with respect to at least one more of the at least three elongatedsections; and wherein at least one of the three or more elongatedsections is configured to maintain a tensile force after any otherelongated section is completely severed from the first body.
 32. Thedevice of claim 31, wherein the first body further comprises a rotatableportion.
 33. The device of claim 31, wherein the length of at least oneof the three or more elongated sections is configured to be adjustedwhile maintaining a tensile force and without changing the length of anyother elongated section.
 34. The device of claim 23, wherein at leastone of the two or more elongated sections is configured to maintain atensile force after any other elongated section is completely severedfrom the first body.
 35. A method for treating a wound, comprising:mechanically coupling two or more elongated sections to tissue at two ormore locations around the wound, the two or more elongated sectionsbeing attached to a rotatable portion comprising at least one firstopening configured for attachment to a reduced pressure source and atleast one fluid passage extending through the rotatable portion and influid communication with the at least one first opening; and adjusting alength of at least one of the two or more elongated sections to pull thetissue at the two or more locations around the wound closer together.36. The method of claim 35, wherein each of the two or more elongatedsections are flexible.
 37. The method of claim 35, wherein mechanicallycoupling the two or more elongated sections to tissue comprisesattaching the two or more elongated sections directly to tissuesurrounding the wound.
 38. The method of claim 35, wherein mechanicallycoupling the two or more elongated sections to tissue comprisesattaching a flexible sheet to tissue surrounding the wound and attachingthe two or more elongated sections to the sheet.
 39. The method of anyone of claims 37-38, wherein the two or more elongated sections areattached with an adhesive.
 40. The method of claim 39, wherein the twoor more elongated sections are attached without penetrating the tissue.41. The method of claim 35, wherein the two or more elongated sectionsinclude two elongated sections that extend in substantially oppositedirections from the rotatable portion.
 42. The method of claim 41,wherein each of the two or more elongated sections, comprise: a pair ofsubstantially parallel elongated arms adjustably connected to therotatable portion; a connector extending between a first end of the pairof elongated arms; and a handle region extending between second ends ofthe pair of elongated arms of each of the two elongated sections,wherein each pair of elongated arms extends from the first endspositioned on one side of the rotatable portion to the second endspositioned on an opposite side of the rotatable portion and eachconnector of the two elongated sections is located on an opposite sideof the rotatable portion from one another.
 43. The method of claim 42,wherein adjusting the length of the two or more elongated sectionscomprises applying force to handle regions extending between the secondend of each pair of elongated arms of the two elongated sections to movethe handle regions further apart from one another and move theconnectors closer to one another.
 44. The method of claim 43, furtherincluding engaging a locking mechanism to prevent movement of theconnectors in at least one direction.
 45. The method of claim 35,comprising: mechanically coupling six or more elongated sections totissue at six or more locations around a wound; and creating tension inthe six or more elongated sections to pull the tissue at the six or morelocations around the wound closer together.
 46. The method of claim 35,comprising: mechanically coupling four or more elongated sections totissue at four or more locations around a wound; and creating tension inthe four or more elongated sections to pull the tissue at the four ormore locations around the wound closer together.
 47. The method of claim35, wherein attaching each of the two or more elongated sections to therotatable portion comprises passing an end portion of each of theelongated sections into elongated section receiving portions of therotatable portion.
 48. The method of claim 47, wherein the elongatedsection receiving portions and the elongated sections form a lockingmechanism such that the elongated sections can be passed into theelongated section receiving portions but cannot be pulled out of theelongated section receiving portions.
 49. The method of claim 48,wherein the locking mechanism comprises a plurality of ridges positionedon a surface of each of the elongated sections.
 50. The method of claim35, wherein creating tension in the two or more elongated sectionscomprises rotating the rotatable portion to shorten the elongatedsections.
 51. The method of claim 49, further comprising engaging alocking mechanism configured to allow the rotatable portion to rotate ina first direction but not in a second direction opposite the firstdirection.
 52. The method of claim 51, further comprising reversing thelocking mechanism to allow the rotatable portion to rotate in the seconddirection but not in the first direction.
 53. The method of claim 51,further comprising releasing the locking mechanism to allow therotatable portion to rotate in the first direction and the seconddirection.
 54. The method of claim 35, further comprising adjusting aposition that one or more connectors are attached to the two or moreelongated sections.
 55. The method of claim 35, further comprisingadjusting a length of one or more connectors attached to at least one ofthe elongated sections.
 56. The method of claim 55, wherein adjustingthe length of one or more connectors comprises adjusting a position of atab portion of at least one of the connectors within a tab receivingportion of the connector to change the distance from the tab receivingportion to the end of one of the elongated sections attached to the tabportion.
 57. The method of claim 56, further comprising preventing thetab portion of at least one of the connectors from moving out of the tabreceiving portion.
 58. The method of claim 35, further comprisingpositioning a flexible sheet over the wound to seal the wound.
 59. Themethod of claim 58, wherein the sheet is positioned under the rotatingportion and the two or more elongated sections are mechanically coupledto a top surface of the sheet.
 60. The method of claim 58, wherein thesheet is positioned on top of the rotatable portion and the two or moreelongated sections are attached directly to the tissue surrounding thewound.
 61. The method of claim 58, further comprising attaching areduced pressure therapy system to the rotatable portion to providereduced pressure therapy to the wound.
 62. The method of claim 61,further comprising placing a porous material body at least partiallywithin the wound.
 63. A method for treating a wound, comprising:attaching a sheet of flexible material to tissue along a perimetersurrounding the wound; mechanically coupling two or more elongatedsections to the tissue at two or more locations around the wound, thetwo or more elongated sections being attached to a first body comprisingat least one first opening configured for attachment to a reducedpressure source and at least one fluid passage extending through thefirst body and in fluid communication with the at least one firstopening; adjusting a length of at least one of the two or more elongatedsections; and applying and maintaining a negative pressure beneath thesheet of flexible material while the flexible sheet of material is incontact with the tissue along the perimeter.
 64. The method of claim 63,wherein mechanically coupling the two or more elongated sections totissue comprises attaching the two or more elongated sections to thesheet.